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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06113822
Other study ID # FiratCerrahi
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date October 30, 2023

Study information

Verified date November 2023
Source Firat University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to determine the effect of body mass index (BMI) and anxiety on masseter muscle thickness by using ultrasonography.


Description:

The aim of this study is to determine the effect of body mass index (BMI) and anxiety on masseter muscle thickness by using ultrasonography. A total of 68 patients were included in this study. Height and weight of the patients were measured. BMI was calculated. The Control Group Without Anxiety - Normal BMI (15 patients) was composed of patients in general. Working groups were formed as High BMI & Anxiety Normal (19 patients), Normal BMI & High Anxiety (15 patients), and High BMI & High Anxiety (19 patients). The Hospital Anxiety Depression Scale (HADS) was applied to the participants. Muscle thickness measurements were first measured by using the high-frequency linear scanning probe of an ultrasound device to measure the contraction and relaxation of the right masseter muscle. Then, the contraction and relaxation of the left masseter muscle was measured.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date October 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - The study group consisted of individuals between the ages of 18 and 45 who, according to an examination of the masseter muscles under the 'Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD),' had the presence of pain in at least one region in the palpation made from three regions (origin, center, attachment zone) or had pain in chewing muscles in the preceding month. Exclusion Criteria: - Exluded from the study where those who had experienced any systemic discomfort from the study group, those who had undergone acute temporomandibular joint trauma, those who had experienced early occlusion of the teeth, those who were using any moving dental prosthesis, those with clenching habits, those who use cigarette-alcohol, those with temporomandibular joint discomfort, and those with unilateral chewing habits.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ultrasonography
We used ultrasonography to measure the patients' masseter muscle thickness. Measurements were performed simultaneously for both the right and left sides using a high frequency linear scanning probe (13-6 MHz) of an ultrasound device (Fujifilm Sonosite Edge II). In order to prevent possible artifacts and oblique imaging, the probe was kept perpendicular to the skin surface, and the distance between the location of the hyperechoic linear appearance of the mandibular and temporal bone in the transverse section and the muscular fascia were measured.

Locations

Country Name City State
Turkey Firat University Elazig Elazig

Sponsors (1)

Lead Sponsor Collaborator
Oguzhan Deveci

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary BMI and anxiety Increased BMI and the presence of anxiety cause thickening of the masseter muscle. 2022
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